Pouches with multi-layer walls for improved durability and protection of medical devices

ABSTRACT

A flexible, sterilizable pouch includes a first wall coupled to a second wall and a cavity defined between the first wall and the second wall. The cavity is configured to receive a medical device, and the pouch is configured to seal the medical device within the cavity. At least one of the first wall and the second wall of the pouch includes two layers. Each layer is coupled to the adjacent layer such that a breach in any one layer of the multi-layered wall will not breach the seal of the pouch. A pocket may be formed between the layers of the multi-layered wall and may include a gas under pressure to inflate the corresponding wall to an inflated state.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/716,859, filed Sep. 27, 2017, which claims the benefit under 35U.S.C. § 119(e) of the filing date of U.S. Provisional Application No.62/400,205 filed Sep. 27, 2016, the contents of each of which areincorporated by reference herein, in their entirety.

FIELD OF THE INVENTION

The present invention relates to sterilizable, flexible medical devicepouches. More particularly, the present invention relates to medicaldevice pouches with multi-layer walls for improved durability andprotection.

BACKGROUND OF THE INVENTION

Sterilizable, flexible pouches, hereafter referred to as pouches, formaintaining the sterility of objects, such as medical devices, forsurgical applications have been utilized for many years. Such pouchestypically utilize a bag fabricated from flexible, non-porous plasticssuch as polyethylene and/or gas-permeable materials such as a DuPontproduct called Tyvek®. Sterilization is accomplished after sealing themedical device within the pouch by exposing the sealed pouch to, forexample, a sterilization gas such as ethylene oxide (EtO) or steam, orradiation such as an electron beam or gamma radiation.

In an example, a pouch may utilize a gas-permeable membrane as a firstlayer of the pouch. The gas-permeable layer is peelably adhered to asecond layer of the pouch. When the medical device stored therein is tobe removed, the first layer is separated or peeled from the second layerand the medical device removed.

Sterilizable pouches are generally formed from a continuous strip orstrips of materials on an intermittent feed heat sealing machine. Anopening to access the pouch is left unsealed such that a medical devicemay be placed therein. Once the medical device is placed within thepouch, the opening is sealed with a heat sealing machine and the pouchand the medical device are sterilized with a selected sterilizationprocess.

These pouches offer sterile presentation and opening in a smallfootprint. Additionally, the pouches are low cost, easy to handle, andreadily disposable. However, these pouches are not particular durableand may fail during transport, handling, and/or storage. Morespecifically, a breach, or hole may form in a layer of the pouch,sometimes due to a shipping carton rubbing against the pouch duringtransport. Alternatively, the medical device stored within the pouch mayrub against the layers of the pouch form the inside and cause a breach.Any breach in a layer of the single layer pouch renders the medicaldevice therein unsterile and not suitable for immediate service.

Moreover, the current pouches afford the medical device stored withinonly minimal protection from damage during transportation, handling andstorage. Accordingly, there is a need for sterilizable, flexible medicaldevice pouches with improved durability. There is also a need forsterilizable, flexible medical device pouches that afford betterprotection to enclosed medical devices.

BRIEF SUMMARY OF THE INVENTION

Embodiments here of relate to a flexible, sterilizable pouch including afirst wall, a second wall coupled to the first wall, and a cavitydefined between the coupled first wall and second wall. The cavity isconfigured to receive a medical device, and the pouch is configured toseal the medical device within the cavity. At least one of the firstwall and the second wall includes more than one layer, with each layercoupled to the adjacent layer. A breach in any one layer of themulti-layered first wall or second wall will not breach the seal of thepouch.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following description of embodiments hereof asillustrated in the accompanying drawings. The accompanying drawings,which are incorporated herein and form a part of the specification,further serve to explain the principles of the invention and to enable aperson skilled in the pertinent art to make and use the invention. Thedrawings are not to scale.

FIG. 1 depicts a planar view of a pouch with a multi-layer wall inaccordance with embodiments hereof.

FIG. 2 depicts an exploded perspective view of an embodiment of thepouch of FIG. 1.

FIG. 3 depicts a longitudinal cross-sectional view of the pouch taken atline 3-3 of FIG. 2 with the pouch sealed.

FIG. 4 depicts an exploded perspective view of a pouch in accordancewith another embodiment hereof.

FIG. 5 depicts a longitudinal cross-sectional view of the pouch taken atline 5-5 of FIG. 4 with the pouch sealed.

FIG. 6 depicts an exploded perspective view of a pouch in accordancewith another embodiment hereof.

FIG. 7 depicts a longitudinal cross-sectional view of the pouch taken atline 7-7 of FIG. 6 with the pouch sealed.

FIG. 8 depicts an exploded perspective view of a pouch in accordancewith another embodiment hereof, wherein the pouch includes a pocketconfigured to receive a gas.

FIG. 9 depicts a longitudinal cross-sectional view of the pouch taken atline 9-9 of FIG. 8 with the pouch sealed.

FIG. 10 depicts a cross-sectional view of the pouch taken at line 10-10of FIG. 8 with the pouch sealed.

FIG. 11 depicts an exploded perspective view of a pouch in accordancewith another embodiment hereof, wherein the pouch includes a pocketconfigured to receive a gas.

FIG. 12 depicts a longitudinal cross-sectional view of the pouch takenat line 12-12 of FIG. 11 with the pouch sealed.

FIG. 13 depicts a cross-sectional view of the pouch taken at line 13-13of FIG. 11 with the pouch sealed.

FIG. 14 depicts an exploded perspective view of a pouch in accordancewith another embodiment hereof, wherein the pouch includes pockets and aperforation.

FIG. 15 depicts a longitudinal cross-sectional view of the pouch takenat line 15-15 of FIG. 14 with the pouch sealed.

FIG. 16 depicts a cross-sectional view of the pouch taken at line 16-16of FIG. 14 with the pouch sealed.

FIG. 17 depicts an exploded perspective view of a wall of a pouchaccording to an embodiment hereof, wherein the wall includes a pocket.

FIG. 18 depicts an exploded perspective view of a wall of a pouchaccording to another embodiment hereof, wherein the wall includes apocket.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Although the description of embodiments hereof is in thecontext of pouches used for sterilization, storage and transportation ofmedical devices, pouches described herein can also be used in otherapplications and for other devices. Furthermore, there is no intentionto be bound by any expressed or implied theory presented in thepreceding technical field, background, brief summary or the followingdetailed description.

Embodiments of the present invention disclose a multi-layer,sterilizable, and flexible medical device pouch (hereafter referred toas a “pouch”) also referred to as a bag, receptacle, or compartment,with improved durability. Embodiments hereof further disclose poucheswith improved protection of the medical devices stored therein. Thepouches may be configured to specific medical device products needs toimprove the robustness of the component and ensure sterility is notcompromised through testing and hence in the field.

A pouch 100 in accordance with an embodiment hereof is shown in FIGS.1-3. The pouch 100 includes a first edge 102, a second edge 104 oppositethe first edge 102, a third edge 106, and a fourth edge 108 opposite thethird edge 106, as shown in FIG. 1. The pouch 100 further includes afirst wall 118 and a second wall 120, as shown in FIGS. 2-3. A cavity122 is defined between the first wall 118 and the second wall 120, asdescribed below. The cavity 122 is configured to receive an object, suchas a medical device 900, therein, as shown in FIG. 3. The pouch 100 isconfigured to seal the medical device 900 within the cavity 122 asdescribed below.

In the embodiment of FIGS. 1-3, the first wall 118 includes a firstlayer or web 110, and a second layer 112. As used herein the term“layer” or “web” means a formed sheet that may be a laminate of severallayers formed together. Thus, a laminate with several materials formedtogether as a single sheet is a single layer, not more than one layer,as would be understood by those skilled in the art. The first layer 110is coupled to the second layer 112 at a first seal 124 in the regions A,B, C, and D to form the first wall 118, as shown in FIG. 2. The firstand second layers 110 may be sealed to each other by using pressurecombined with heat creating a welded or peelable seal. The regions A, B,C, and D, as used herein to describe locations where two layers of awall are attached to each other is intended to such that the first seal124 extends to the edges of each layer. In such a manner, the first wall118 presents itself to a user as a single layer, rather than as twolayers. This prevents a user from peeling the first and second layers110, 112 apart rather than peeling the first and second walls 118, 120apart, as described in more detail below. Further, it is preferable thatregions away from regions A, B, C, and D of the first and second layers110, 112 are not attached to each other to permit relative movementbetween the first and second layers.

The second wall 120 includes a single, third layer 114. The first wall118 is coupled to the second wall 120 at a second seal 126 in regions E,F, G, and H. The regions E, F, G, and H, as used herein to describewhere two walls are attached to each other is intended to includeregions both at the edges of walls as well as to regions that are nearthe edges of the walls. The second seal 126 may be accomplished via heatsealing such as by using pressure combined with heat to create a weldedor peelable seal.

In the embodiment of FIGS. 1-3, the first layer 110 is formed of agas-impermeable film or foil material, such as, but not limited toaluminum, low-density polyethylene (LDPE), nylon, or polyester. Thefirst layer 110 provides an effective barrier against the migration ofmicro-organisms, including bacteria. The material of the first layer 110is selected such that the first layer 110 may be sealed with the secondlayer 124 along the first seal 124.

In the embodiment of FIGS. 1-3, the second layer 112 and the third layer114 are each formed of a gas-permeable material such as, but not limitedto a spun-bonded polyolefin marketed by DuPont under the name Tyvek® ormedical grade paper. The second and third layers 112, 114 each permitsterilization of the pouch 100 and the medical device 900 disposedwithin the cavity 122 by methods such as, but not limited to ethyleneoxide gas (EtO), steam sterilization, or other suitable sterilizationmethods using a temperature at or below 260° F. Further, the second andthird layers 112, 114 each provide an effect barrier against migrationof micro-organisms, particularly bacteria. The material of the secondlayer 112 is selected such that it can be sealed to the first layer 110along first seal 124. The materials of the first, second, and thirdlayers are selected such that they can be sealed along second seal 126.

The pouch 100 is assembled by superposing the first layer 110 over thesecond layer 112 and subjecting the first layer 110 and the second layer112 to a sealing process such that the first seal 124 is formed in theregions A, B, C, and D between the first layer 110 and the second layer112. Formation of the first seal 124 couples the first layer 110 to thesecond layer 112 to form the first wall 118.

The first wall 118 is superposed over the second wall 120, in thisembodiment the single, third layer 114, and subjected to a sealingprocess to form the second seal 126 in the regions E, F, and G to couplethe first wall 118 to the second wall 120.

The second seal 126 defines the outer limits of the cavity 122. As notedabove, at this point in the manufacture of the pouch 100, the only threesides of the second seal 126 (regions E, F, and G) between the firstwall 118 and the second wall 120 have been formed. In order to permitthe placement of a medical device, such as the medical device 900 withinthe cavity 122, the second seal 126 between the first wall 118 and thesecond wall 120 is omitted from the region H. Thus, an opening 129between the first and second walls 118, 120 to the cavity 122 isprovided at region H. In the embodiment of FIGS. 1-3, the opening 129 isprovided at the fourth edge 108 of the pouch 100, but the opening 129may be formed along any of the edges. While shown in FIG. 2 with theopening 129 extending generally fully across the length of the fourthedge 108, this is by way of example and not limitation, and the opening129 may extend for a lesser distance. The medical device 900 may then beplaced within the cavity 122. The pouch 100 is subjected to anothersealing process to form the second seal 126 in the region H to seal themedical device 900 within the cavity 122.

The second seal 126 at region H may be formed at a differentlocation/time than the other regions. For example, and not by way oflimitation, a pouch manufacturer may provide the pouch 100 with thefirst seal 124 at regions A, B, C, and D, and the second seal 126 atregions E, F, and G. The pouch manufacturer may ship the pouch 100 to amedical device manufacturer. The medical device manufacturer may insertthe medical device 900 into the cavity 122 and provide the second seal126 at the region H. Alternatively, the medical device manufacturer mayship the medical device to the pouch manufacturer who inserts themedical device 900 into the cavity 122 and provides the second seal 126at the region H. Other combinations may also be used, such as a thirdparty receiving both the pouch 100 and the medical device 900, insertingthe medical device 900 into the pouch 100, and then providing the secondseal at region H.

The pouch 100 may next be sterilized using any suitable method, such as,but not limited to exposure to ethylene oxide (EtO), electron beamradiation, gamma radiation, or steam at or below 260° F. for a requisiteduration to ensure sterility of the pouch 100 and the medical device 900disposed therein. When the package 100 and the medical device 900disposed therein has been adequately sterilized, the package 100 may beplaced within a shipping carton or container for transport, storage, andhandling,

When it is desired to use the medical device 100, the medical deviceneeds to be removed from the pouch 100. In the embodiment shown in FIG.1-3, the second seal 126 between the first wall 118 and the second wall120 at region H is spaced from the fourth edge 108, thereby creating afirst flange 130 in the first wall 118 and a second flange 132 in thesecond wall 120, as shown in FIG. 1. The pouch 100 is opened by graspingthe first flange 130 and the second flange 132, and pulling the firstand second flanges 130, 132 apart. Although the first and second flanges130, 132 are described at fourth edge 108, wherever second seal 126 isspaced from one of the edges of the pouch 100, respective flanges areformed which may be used to open the pouch 100. As explained above, itis preferable that the first seal 124 (between first and second layers110, 112) at regions A, B, C, and D is disposed at the edges of thefirst and second layers 110, 112 such that the first and second layers110, 112 appear as a single layer to the user. This prevents the userfrom separating the first and second layers 110, 112 from each other,rather than the first and second walls 118, 120 from each other.However, if the second seal 126 is disposed at the first, second, andthird edges 102, 104, 106, then the first seal 124 between the first andsecond layers 110, 112 may only need to be disposed at the edges of thefirst and second layers 110, 112 at region D (fourth edge 108).

As briefly explained above, portions of the first and second layers 110,112 of the first wall 118 may move independent of each other between theregions of the first seal 124. With the independent movement, thelikelihood of a breach or hole in both the first layer 110 and thesecond layer 112 is lessened or reduced by the redundancy of thedouble-layer construction of the first wall 118 and the independentmovement of the first layer 110 and the second layer 112 of the firstwall 118. More specifically, when the medical device 900 is disposedwithin the cavity 122, the medical device 900 is adjacent to and incontact with only the second layer 112. Thus, movement of the medicaldevice 900 relative to the second layer 112 may wear the second layer112, but will not contact, and therefore will not rub, wear, or breachthe first layer 110 until after the second layer 112 has been breached.Conversely, when the pouch 100 is placed in a shipping carton fortransport, handling, or storage, the first layer 110 is adjacent to andin contact with the carton. Movement of the pouch 100 relative to thecarton may wear the first layer 110, but will not contact, and thereforewill not rub, wear, or breach the second layer 112 until after the firstlayer 112 has been breached. Thus, a breach in any one layer of themulti-layer first wall 118 will not compromise the sterility of themedical device 900, thereby improving the durability of the pouch 100.

FIGS. 1 and 4-5 show a pouch 200 in accordance with another embodimenthereof. The pouch 200 includes a first edge 202, a second edge 204, athird edge 206, a fourth edge 208, a first layer 210, a second layer212, a third layer 214, a first wall 218, a second wall 220, a cavity222, a first seal 224, a second seal 226, a first flange 230, and asecond flange 232 that are similar to the similarly numbered items ofthe pouch 100. Therefore, a detailed explanation of the construction andalternatives of these similar components will not be described. However,the second wall 220 of the pouch 200 further includes a fourth layer216.

In the embodiment of FIGS. 4-5, the second wall 220 includes the thirdlayer 214 coupled to the fourth layer 216 by a third seal 228 in theregions A′, B′, C′, and D′, as shown in FIG. 4. The cavity 222 isdefined between the first wall 218 and the second wall 220.

The first layer 210, the second layer 212, and the third layer 214 areformed of materials as described previously with respect to same layersof the pouch 100 of FIGS. 1-3. The fourth layer 216 is formed of agas-impermeable film or foil material, such as, but not limited toaluminum, low-density polyethylene (LDPE), nylon, or polyester. Thefourth layer 216 may be formed of the same material as the first layer210. The material of the fourth layer 216 is selected such that it maybe sealed to the third layer 214 and the third seal 228 and such that itmay be sealed with the first, second, and third layers by the secondseal 226.

The fourth layer 216 includes a plurality of perforations 238. Theplurality of perforations 238 are apertures or openings through thefourth layer 216. The plurality of perforations 238 permit gas to passthrough the fourth layer 216 such that sterilization passes through theperforations 238, the third layer 214, into the cavity 222, and throughthe second layer 212. The plurality of perforations 238 may be disposedat any location of the fourth layer 216 within the area defined by thirdseal 228. However, it is preferred that no perforation 238 is locatedadjacent to any sharp edges, ends or protrusions of a medical device 900disposed within the pouch 200. While the plurality of perforations 238are shown in FIGS. 4-5 with a circular shape, it will be understood thatthis is by way of example and not limitation, and the plurality ofperforations 238 may have other shapes including but not limited toovals, rectangles, or other suitable shapes. Moreover, each perforation238 may have the same, or different shape than another perforation 238in any combination. Even further, while the fourth layer 216 is shownwith a specific number of perforations 238, this too is by way ofexample and not limitation, and the fourth layer 216 may have a greateror fewer number of perforations 238.

Assembly of the pouch 200 is similar to the assembly of the pouch 100 ofFIGS. 1-3. The first wall 218 is formed as described previously withrespect to the first wall 118 of FIGS. 1-3. The second wall 220 isassembled by superposing the third layer 214 over the fourth layer 216and subjecting the third and fourth layers 214, 216 to a sealing processsuch that the third seal 228 is formed in the regions A′, B′, C′, and D′between the third layer 214 and the fourth layer 216. The first wall 218is then superposed over the second wall 220 and subjected to a sealingprocess to form the second seal 226 in the regions E, F, and G, aspreviously described with respect to the pouch 100 of FIGS. 1-3.

When the pouch 200 has been assembled, the medical device 900 disposedwithin the cavity 222 through an opening 229 adjacent the fourth edge208. Next, the pouch 200 is subjected to another sealing process to formthe second seal 226 in the region H to seal the medical device 900within the cavity 222 of the pouch 200.

The pouch 200 may next be sterilized using any suitable method, such as,but not limited to exposure to ethylene oxide (Eta), electron beamradiation, gamma radiation, or steam at or below 260° F. for a requisiteduration to ensure sterility. The perforations 238 in the fourth layer216 permit the use of gas sterilization methods, as the sterilizationgas may pass through the perforations 238 in the impermeable fourthlayer 216 and then proceed through the gas-permeable third and secondlayers 214, 212 and into the cavity 222.

The additional fourth layer 216 of the second wall 220 means thelikelihood of a breach in both the fourth layer 216 and the adjacentthird layer 214 is reduced. Similar to the embodiment of FIGS. 1-3, theportions of the third layer 214 and the fourth layer may move relativeto each other in the areas not sealed by third seal 228. When themedical device 900 is disposed within the cavity 222, the medical device900 is adjacent to and in contact with only the third layer 214.Movement of the medical device 900 relative to the third layer 214 willwear the third layer 214, but will not contact, rub, wear, or breach thefourth layer 216 until after the third layer 214 has been breached.Conversely, when the pouch 100 is placed in a shipping carton fortransport, handling, and storage, the fourth layer 216 is adjacent toand in contact with the carton, and movement of the pouch 200 relativeto the carton will wear the fourth layer 216, but will not contact, rub,wear, or breach the third layer 214 until after the fourth layer 216 hasbeen breached. A breach in any one layer of the multi-layer first wall118 or the multi-layer second wall 220 will not compromise the sterilityof the medical device 900.

Opening of the pouch 200 is similar to the opening of the pouch 100described previously with respect to FIGS. 1-3. In the embodiment shownin FIGS. 1 and 4-5, the second seal 226 between the first wall 218 andthe second wall 220 at region H is spaced from the fourth edge 208,thereby creating a first flange 230 in the first wall 118 and a secondflange 232 in the second wall 220, as shown in FIG. 1. The pouch 200 isopened by grasping the first flange 230 and the second flange 232, andpulling the first and second flanges 230, 232 apart.

A pouch 300 in accordance with another embodiment hereof is shown inFIGS. 1 and 6-7. The pouch 300 includes a first edge 302, a second edge304, a third edge 306, a fourth edge 308, a first layer 310, a secondlayer 312, a third layer 314, a fourth layer 316, a first wall 318, asecond wall 320, a cavity 322, a first seal 324, a second seal 326, athird seal 328, a first flange 330, and a second flange 332. The pouch300 and its components are similar that are similar to the similarlynumbered items of the pouch 200. Therefore, a detailed explanation ofthe construction and alternatives of these similar components will notbe described. However, in contrast to the fourth layer 216 of the pouch200, the fourth layer 316 of the pouch 300 is formed of a gas-permeablematerial such as, but not limited to a spun-bonded polyolefin marketedby DuPont under the name Tyvek® or medical grade paper. Accordingly, thefourth layer 316 does not include perforations because it isgas-permeable. The pouch 300 is constructed in the same manner as thepouch 200 described above, and provides improved durability with amulti-layer configuration for both the first wall 318 and the secondwall 320, as described with respect to the pouch 200 of FIGS. 1 and 4-5.

FIGS. 1 and 8-10 show a pouch 400 in accordance with another embodimentof the present disclosure. The pouch 400 includes a first edge 402, asecond edge 404, a third edge 406, a fourth edge 408, a first layer 410,a second layer 412, a third layer 414, a fourth layer 416, a first wall418, a second wall 420, a cavity 422, a first seal 424, a second seal426, a third seal 428, a first flange 430, and a second flange 432.These components of pouch 400 are similar to the similarly numbereditems of the pouch 200. Therefore, a detailed explanation of theconstruction and alternatives of these similar components will not bedescribed. However, in the embodiment of FIGS. 8-10, both the first andsecond layers 410, 412 of the first wall are formed from agas-impermeable material, and both the third and fourth layers 414, 416of the second wall 420 are formed from a gas-impermeable material.Further, the first wall 418 includes a pocket 442 between the first andsecond layers 410, 412, and the second wall 420 includes a pocket 446between the second and third layers 414, 416. Further, the pockets 442and 446 each has an inflated state.

In the embodiment of FIGS. 8-10, the first layer 410, the second layer412, the third layer 414, and the fourth layer 416 are each formed of agas-impermeable film or foil material, such as, but not limited toaluminum, low-density polyethylene (LDPE), nylon, or polyester.

The first wall 418 includes the first layer 410 coupled to the secondlayer 412 by a first seal 424 in the regions A, B, C, and D, and aplurality of fourth seals 440. The pocket 442 is formed between thefirst and second layers 410, 412 and the first and fourth seals 424,440, as shown in FIG. 8. The first wall 418 is configured to receive agas under pressure into the pocket 442 to transition the first wall 418from an uninflated state to and inflated state, as best shown in FIG.10. When in the inflated state, the first wall 418 is configured toprotect a medical device 900 disposed within the cavity 422 of the pouch400 from damage.

Similarly, the second wall 420 includes the third layer 414 coupled tothe fourth layer 416 by the second seal 426 in the regions A′, B′, C′,and D′, and a plurality of fifth seals 444. The pocket 446 is formedbetween the third and fourth layers 414, 416 and the second and fifthseals 426, 444, as shown in FIG. 8. The second wall 420 is configured toreceive a gas under pressure into the pocket 446 to transition thesecond wall 420 from an uninflated state to the inflated state, as shownin FIG. 10. When in the inflated state, the second wall 420 isconfigured to protect the medical device 900 disposed within the cavity422 of the pouch 400, as described below.

To assemble the pouch 400, the first layer 410 is superposed over thesecond layer 412, and the first layer 410 and the second layer 412 aresubjected to a sealing process such that the first seal 424 is formed inthe regions A, B, C, and D and the plurality of fourth seals 440 areformed between the first layer 410 and the second layer 412 to couplethe first layer 410 to the second layer 412. A gas under pressure isprovided to the pocket 442 of the first wall 418 to inflate the wall418. The gas flows within the pocket 442 and around the plurality offourth seals 440 to form a plurality of interconnected cushions, pillowsor bubbles 448, as shown in FIG. 10. The firmness of the plurality ofcushions 448 may be adjusted through adjustment of the gas pressureduring the sealing process to customize each pouch 400 for a specificmedical device. Similarly, the third layer 414 is coupled to the fourthlayer 416 by superposing the third layer 414 over the fourth layer 416and subjecting the third layer 414 and the fourth layer 416 to a sealingprocess. The sealing process forms the third seal 428 in the marginalregions A′, B′, C′, and D′ and the plurality of fifth seals 444 betweenthe third layer 414 and the fourth layer 416 of the second wall 420.During the sealing process, a gas under pressure is provided to thepocket 446 to form the second wall 420 in the inflated state. The gasflows within the pocket 446 and around the plurality of fifth seals 442to form a plurality of interconnected cushions, pillows or bubbles 450.

The first wall 418 in the inflated state is superimposed over the secondwall 420 in the inflated state and subjected to a sealing process toform the second seal 426 in the marginal regions E, F, and G. Formationof the second seal 426 couples the first wall 418 to the second wall 420and forms the cavity 422 between the first wall 418 and the second wall420.

When the pouch 400 has been assembled to this point, the medical device900 may be disposed through an opening 429 and received within thecavity 422. The pouch 400 is then subjected to a sealing process to formthe second seal 426 in the marginal region H, thereby sealing themedical device 900 within the cavity 422. The pouch 200 may next besterilized using any suitable method that does not require a gaspathway, such as, but not limited to exposure to electron beam radiationor gamma radiation to ensure sterility.

It is noted that in FIG. 8, the seal lines are shown in only some of thelayers for clarity. Thus, the first seal 424 and the fourth seals 440are shown only in the first layer 410, but they extend to both the firstlayer 410 and the second layer 412 to couple them together. Similarly,the third seal 428 and the fifth seals 444 are shown only in the thirdlayer 414, but they extend to both the third layer 414 and the fourthlayer 416. Similarly, the second seal 426 is shown only in the secondlayer 412, but it extends to the first, second, third, and fourth layers410, 412, 414, and 416.

The multiple layers of the first wall 418 and the second wall 420 eachreduce the likelihood of a breach in the corresponding wall, asdescribed previously with respect to the embodiments of pouches 100,200, and 300 of FIGS. 1-7. Further the cushions 448, 450 of the firstand second walls 418, 420 in the inflated state provide protection tothe medical device 900 stored within the pouch 400, particularly inpotentially high-impact areas. The gas-filled pockets 442, 446 of thefirst and second walls 418, 420, and more specifically, the cushions448, 450 of the first and second walls 418, 420, are each configured toprotect to the medical device 900 disposed therein from damage occurringduring transportation, storage, and/or handling of the pouch 400 toinsure the medical device 900 is delivered in good, usable, and sterilecondition.

It will be understood that the shape of the cushions of each wall of thepouch 400 may be designed to fit snugly within a shipping carton orcontainer to minimize or reduce folding or movement of the pouch 400.The shape of the cushions of each wall may further be designed such thatthe medical device 900 may sit on the cushion, the cushion may surroundthe medical device 900, or a combination thereof. The shape of thecushions may be altered by changing the layout of the correspondingseals of the respective wall, as explained in more detail below.

While described herein as providing a gas under pressure to the pockets442, 446 prior to placing the medical device 900 within the cavity 422of the pouch 400, it will be understood that the gas under pressure maybe provided to the pockets 442, 446 after the medical device 900 hasbeen received within the cavity 422, and during the final sealingprocess. In such a method, at least a portion of the first seal 424between the first and second layers 410, 412 and the third seal 428between the third and fourth layers 414, 416 will not completed untilafter the gas is provided to the pockets 442, 446, respectively.

A pouch 500 in accordance with another embodiment hereof is now shown inFIGS. 1 and 11-13. The pouch 500 includes a first edge 502, a secondedge 504, a third edge 506, a fourth edge 508, a first layer 510, athird layer 514, a fourth layer 516, a first wall 518, a second wall520, a cavity 522, a second seal 526, a third seal 528, a plurality offifth seals 544, a first flange 530, and a second flange 532. Thesecomponents of pouch 500 are similar to the similarly numbered items ofthe pouch 400. Therefore, a detailed explanation of the construction andalternatives of these similar components will not be described. However,in contrast to the pouch 400, the first wall 518 of the pouch 500 ofFIGS. 11-13 includes only a first layer 510 and it is gas-permeable.

The first layer 510 is formed of a gas-permeable material such as, butnot limited to a spun-bonded polyolefin marketed by DuPont under thename Tyvek® or medical grade paper. As the first wall 518 includes onlythe first layer 510, the first wall 518 does not include an inflatedstate or a pocket 540.

To assemble the pouch 500, the first layer wall 518 is superposed overthe second wall 520 in the inflated state, which may be formed asdescribed previously with respect to the second wall 420 of FIGS. 8-10.The superposed first and second walls 518, 520 are subjected to asealing process to form the second seal 526 in the regions E, F, and G.Formation of the second seal 526 couples the first wall 518 to thesecond wall 520 and forms the cavity 522 between the first wall 518 andthe second wall 520.

Similar to FIG. 8, FIG. 11 does not show the seal lines in all of thelayers for clarity of the figure. Thus, the third seal 528 and the fifthseals 544 are shown only in the third layer 514, but they extend to boththe third layer 514 and the fourth layer 516. Similarly, the second seal526 is shown only in the second layer 512, but it extends to the first,third, and fourth layers 510, 514, and 516.

The multiple layers of the second wall 520 reduces the likelihood of abreach through both layers, in this embodiment the third layer 514 andthe fourth layer 516, as described previously. Further the second wall520 in the inflated state is configured to provide protection fromphysical damage to the medical device 900 during transportation,handling, storage and opening of the pouch 400.

A pouch 600 in accordance with another embodiment hereof is shown inFIGS. 1 and 14-16. The pouch 600 includes a first edge 602, a secondedge 604, a third edge 606, a fourth edge 608, a first layer 610, asecond layer 612, a third layer 614, a fourth layer 616, a first wall618, a second wall 620, a cavity 622, a first seal 624, a second seal626, a third seal 628, a plurality of fourth seals 640, a plurality offifth seals 644, a pocket 642 of the first wall 618, a pocket 646 of thesecond wall 620, a first flange 630, and a second flange 632. Thesecomponents of pouch 600 are similar to the similarly numbered items ofthe pouch 400. Therefore, a detailed explanation of the construction andalternatives of these similar components will not be described. However,the pouch 600 of FIGS. 14-16 further includes a perforation 652 throughthe first wall 618. The perforation 652 is sealed by a gas-permeablepatch 654.

As best shown in FIG. 14, the first wall 618 includes the first layer610 coupled to the second layer 612 by a first seal 624 in the marginalregions A, B, C, and D, a plurality of fourth seals 640, and a sixthseal 656. The pocket 642 is formed between the first and second layers610, 612, and the first, fourth, and sixth seals 624, 640, 656. Thesixth seal 656 defines the perforation 652 through the first wall 618.More specifically, the sixth seal 656 defines the perforation 652through both the first layer 610 and the second layer 612. The firstwall 618 is configured to receive a gas under pressure into the pocket640.

The perforation 652 in the first wall 618 is configured to permit gases,such as gasses utilized for sterilization, to flow through the firstwall 618 of the pouch 600 via the perforation 652, as described below.While shown with only one (1) perforation 652, it will be understoodthat more than one (1) perforation 652 may be utilized. Moreover, whilethe perforation 652 is shown in FIG. 14 with a generally circular shape,this is by way of example and not limitation, and the perforation 652may have other shapes including oval, and rectangular shapes. Evenfurther, the perforation 652 may be disposed at any location of thefirst wall 618 suitable for the purposes described herein (i.e., theperforation 652 must extend to the cavity 622), and is not restricted tothe location shown in FIG. 14.

The patch 654 is a gas-permeable material such as materials describedpreviously with respect to the first layer 110 of FIGS. 1-3. The patch654 is disposed over the perforation 652 and is slightly larger in sizethen the perforation 652 such that the patch 654 may be coupled to thefirst wall 618 around the perimeter of the perforation 652. The patch654 is configured to allow gases, such as those utilized in thesterilization process, to pass through the impermeable first and secondlayers 610, 612 of the first wall 618 via the perforation 652 to thecavity 622, but provide an effective barrier against the migration ofmicro-organisms, including bacteria. The patch 654 may be coupled to thefirst layer 610 by methods such as but not limited to adhesives,bonding, welding, fusing, heat sealing or any other suitable method.

Assembly of the pouch 600 is similar to the assembly of the pouch 400described previously, therefore, only the differences in assembly willbe described. The first layer 610 is superposed over the second layer612 and subjected to a sealing process to couple the first layer 610 tothe second layer 612. The first seal 624 is formed in the marginalregions A, B, C, and D, and the plurality of fourth seals 640 and thesixth heat seal 656 are formed between the first layer 610 and thesecond layer 612. A gas under pressure is provided to the pocket 642 ofthe first wall 618 to form and seal the wall 618 in the inflated state.The gas flows within the pocket 642 and around the plurality of fourthseals 440 and the sixth seal 656 to form a plurality of interconnectedcushions, pillows or bubbles 448 and a relative recess in the first wall618 at the perforation 652. The material of the first layer 610 and thesecond layer 612 at the perforation 652 within the sixth seal 656 maynow be removed from the first wall 618 by methods such as, but notlimited to die cutting, melting or other suitable methods. In otherembodiments, the first and second layers 610, 612 may be provided withthe perforations 652 provided and the sixth seal 656 may be made aroundsuch perforations 652.

The second wall 620 is assembled as described with respect to the secondwall 420 of the pouch 400. Further, the first and second walls 618, 620of the pouch 600 are then attached to each other as described previouslywith respect to the pouch 400 of FIGS. 8-10.

The multiple layers of the first wall 618 and the second wall 620 eachreduce the likelihood of a breach in the corresponding wall, asdescribed previously. Further, the first wall 618 in the inflated stateand the second wall 620 in the inflated state each provide a cushion andadditional protection to the medical device 900 stored within the pouch600, as described previously with respect to the pouch 400 of FIGS.8-10. The perforation 652 in the first wall 618 permits the use of gasprocesses for sterilization. The sterilizing gas may pass through thepatch 654 to the cavity 622 and the medial device 900 disposed therein.

Similar to FIGS. 8 and 11, FIG. 14 does not show the seal lines in allof the layers for clarity of the figure. Thus, the first seal 624 andthe fourth seals 640 are shown only in the first layer 610, but theyextend to both the first layer 610 and the second layer 612 to couplethem together. Similarly, the third seal 628 and the fifth seals 644 areshown only in the third layer 614, but they extend to both the thirdlayer 614 and the fourth layer 616. Similarly, the second seal 626 isshown only in the second layer 612, but it extends to the first, second,third, and fourth layers 610, 612, 614, and 616.

While the embodiments of the FIGS. 8-10, 11-13, and 14-16 have eachshown wall with the fourth and/or fifth seals in a linear shape to formlinearly aligned adjacent cushions, this is not meant to be limiting,and other shapes may be utilized. In an example shown in FIG. 17, afirst wall 1718 includes a first layer 1710 and a second layer 1712. Afirst seal 1724 and a fourth seal 1740 attach the first layer 1710 tothe second layer 1712. In the embodiment of FIG. 17, the fourth seal1740 is circular in shape. When gas under pressure is supplied to apocket 1742 of the first wall 1718, the gas fills the pocket 1742between the first layer 1710, the second layer 1712, the first seal1724, and the fourth seal 1740. The gas does not flow within theboundaries of the fourth seal 1740. Thus, a recess 1760 is formed withinthe first wall 1718 within the fourth seal 1740. The recess 1760 may bedisposed at a desired location to provide additional clearance to acorresponding portion of a medical device (not shown in FIG. 17).Although described with one (1) recess 1760, this is by way of exampleand not exception and more than one (1) recess 1760 may be utilized.While a first wall 1718 has been utilized in the example describedherein, this is by way of example and not limitation, and it will beunderstood that the example described herein is equally applicable to asecond wall of a pouch of embodiments of the present disclosure.

FIG. 18 shows another example of a first wall 1818 including a pluralityof fourth seals 1840 in a mattress or quilted pattern. When gas underpressure is supplied to a pocket 1842 of the first wall 1818, the gasfills the pocket 1842 between the first layer 1810, the second layer1812, the first seal 1824, and around the plurality of fourth seals1840, creating a mattress pattern of cushions 1848. Although shown witha specific number of fourth seals 1840, this is by way of example andnot limitation, and more or fewer fourth seals 1840 may be utilized tocreate more or fewer cushions 1848. Moreover, while described with afirst wall 1818, it will be understood that the example described hereinis equally applicable to a second wall of a pouch of embodiments of thepresent disclosure.

Although the formation of the various seals has been describedspecifically as separate processes, this is by way of example and notlimitation, and it may be advantageous to form multiple sealssimultaneously.

While the pouches described herein are shown with a generallyrectilinear shape, this is by way of example and not limitation, and itwill be understood that embodiments of pouches of the present disclosuremay assume other shapes, such as oval, round, or virtually any desiredshape.

Although described herein with specific examples of materials for thelayers of the pouch embodiments, the specific materials of each layer ofeach embodiment may be selected based on the desired durabilityrequirements of the pouch, permeability, and the sterilization methodused.

While various embodiments according to the present invention have beendescribed above, it should be understood that they have been presentedby way of illustration and example only, and not limitation. Variouschanges in form and detail can be made therein without departing fromthe spirit and scope of the invention. Further, each feature of each ofthe embodiments described may be combined and/or interchanged with thefeatures of any of the other embodiments described herein. Thus, thebreadth and scope of the present invention should not be limited by anyof the above-described exemplary embodiments, but should be defined onlyin accordance with the appended claims and their equivalents.

1-7. (canceled)
 9. A flexible, sterilizable pouch, comprising: a firstwall; a second wall coupled to the first wall; and a cavity definedbetween the first wall and the second wall, wherein the cavity isconfigured to receive a medical device, wherein the pouch is configuredto seal the medical device within the cavity; and wherein the first wallincludes a first layer coupled to an adjacent second layer, the firstand second layers being gas-impermeable, wherein the first wall furtherincludes a pocket between the first layer and the second layer, whereinthe pocket is configured to receive a gas under pressure, wherein whenthe gas is received within the pocket, the first wall transitions formfrom an uninflated state to an inflated state; and wherein the firstwall in the inflated state is configured to protect the medical devicedisposed within the cavity of the pouch.
 10. The pouch of claim 9,wherein the pocket includes a plurality of cushions configured toprotect the medical device disposed within the cavity of the pouch whenthe first wall is in the inflated state.
 11. The pouch of claim 10,wherein the first wall further includes at least one perforationextending through the first layer and the second layer of the firstwall.
 12. The pouch of claim 11, wherein in the first wall furtherincludes a gas-permeable patch coupled to the first wall, wherein thepatch is configured to seal the perforation.
 13. The pouch of claim 19,wherein the third layer is a gas-impermeable layer and the fourth layeris a gas-impermeable layer.
 14. The pouch of claim 13, wherein thesecond wall further includes a pocket between the third layer and thefourth layer, wherein the pocket is configured to receive a gas underpressure, wherein when the gas is received within the pocket, the secondwall transitions form an uninflated state to an inflated state; andwherein the second wall in the inflated state is configured to protectthe medical device disposed within the cavity of the pouch.
 15. Thepouch of claim 14, wherein the pocket includes a plurality of cushionsconfigured to protect the medical device disposed within the cavity ofthe pouch when the second wall is in the inflated state.
 16. The pouchof claim 9, wherein the first layer and the second layer are sealedtogether along the edges of the first layer and the second layer. 17.The pouch of claim 16, wherein the first layer and the second layer areconfigured to move relative to each other between the sealed edges. 18.The pouch of claim 9, wherein first wall and the second wall are sealedto each other such that at least at one edge of the first and secondwalls, the seal is spaced from the at least one edge to form a firstflange in the first wall and a second flange in the second wall forgrasping to open the pouch.
 19. The pouch of claim 9, wherein the secondwall includes a third layer and a fourth layer such that each of thefirst and second walls includes two layers.
 20. The pouch of claim 9,wherein the second wall comprises a gas-permeable layer.
 21. The pouchof claim 10, further comprising seals between the first layer and thesecond layer forming the plurality of cushions.
 22. The pouch of claim21, wherein the seals are disposed longitudinally.
 23. The pouch ofclaim 21, wherein seals comprise point seals such that the plurality ofcushions are in a mattress pattern.
 24. The pouch of claim 13, furthercomprising seals between the third layer and the fourth layer formingthe plurality of cushions.
 25. The pouch of claim 24, wherein the sealsare disposed longitudinally.
 26. The pouch of claim 24, wherein sealscomprise point seals such that the plurality of cushions are in amattress pattern.